The quality standards of the Ph. Eur. are essential for ensuring the quality of all medicines available in Europe and beyond. These standards are usually composed of a documentary standard (monograph or general method) and physical standards (reference standards).
Understanding the links between them is essential for the appropriate application of the Ph. Eur. quality standards.
In this module, you will learn about the chemical reference standards used in conjunction with Ph. Eur. monographs and general chapters. It covers how they are scientifically established, provides additional information on their use and addresses requirements of GMP inspectors regarding reference standards. It also provides practical tips on how best to handle them and points to note when ordering and addresses questions that you may have as a user.

 Download the virtual training agenda.

Target audience

The module is of interest to all individuals involved in drug development, R&D, pharmaceutical quality assurance and quality control, as well as those working in regulatory affairs.

It is ideal for anyone looking to build a solid foundation knowledge of both the Ph. Eur. and the CEP Procedure, such as recent graduates or early-career professionals.

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Duration: 1 hour, 38 minutes

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• Ph. Eur. Reference Standards: establishment and use by Perrine Deffosez 
• What GMP inspectors expect on Reference Standards by Oisín Daly 
• Handling-dispatch - Where to find useful information and other practicalities by Maryline Clauzel 

Other Events / Training Sessions  

• EDQM Virtual Training Programme: independent modules on the Ph. Eur., reference standards and the CEP Procedure
• Joint EDQM-USP Webinar on “Orthogonal Analytical Methods for the Characterisation of Pharmacopoeial Reference Standards”
• Joint EDQM-USP Webinar on “Overcoming obstacles in establishing pharmacopoeial reference standards: insights from case studies”

On-Demand Webinars

Suggested viewing and reading

The EDQM recommends participants watch and read the pre-training materials listed below before watching a training module. The materials will help participants familiarise themselves with some basic concepts and topics which are not covered in detail in the webinar sessions.

• European regulations for medicines: Place and role of the EDQM and the European Pharmacopoeia (Ph. Eur.)  - Duration: 27 minutes
• General concepts in the European Pharmacopoeia - Duration: 28 minutes
• How to participate in the elaboration of the European Pharmacopoeia  - Duration: 24 minutes
• Find your way in the new Ph. Eur. Online platform: new features, advanced navigation and efficient searching - Duration: 51 minutes
• Find your way in Pharmeuropa – Duration: 12 minutes
• Find your way in the Knowledge database – Duration: 6 minutes
• Ph. Eur. Reference Standards: General Aspects - Duration: 22 minutes
• CEP at a glance